BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS

    MDR report key: 17650879 · Received August 30, 2023

    Report

    Report Number
    9615102-2023-00136
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    May 4, 2022
    Report Date
    August 30, 2023
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    BZC
    UDI-DI
    04250892904863
    PMA / PMN Number
    K181524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING FURTHER INVESTIGATION REGARDING THE MANUFACTURER REPORT #9615102-2022-00129, IT WAS DISCOVERED THAT THIS SECOND COMPLAINT WITH A SIMILAR ISSUE WAS REGISTERED. THE RISK REGARDING THIS COMPLAINT WAS INITIALLY NOT RECOGNIZED, THEREFORE IT WILL BE REPORTED NOW. THE INVESTIGATION RESULTED IN A BUG WITHIN THE SOFTWARE SES 3.20 THAT SHOWED AN INCORRECT CLASSIFICATION BAR ON METHACHOLINE REPORT. A RISK ASSESSMENT RESULTED IN A MEDIUM HEALTH RISK. THEREFORE, A CAPA WAS INITIATED. THE ISSUE IS ADDRESSED IN A PATCH FOR SENTRYSUITE VERSION 3.20 WHICH HAS ALREADY BEEN RELEASED. NO FURTHER ADVERSE EVENT REGISTERED. H3 OTHER TEXT : SOFTWARE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT ON THE METHACHOLINE CHALLENGE TEST REPORTS, THAT IF THE RESULT IS NEGATIVE BUT THE PD20 IS REACHED IN THE "NORMAL" RANGE, THE SENTRYSUITE 3.20.3 SOFTWARE OF THE VYNTUS APS INCORRECTLY INTERPRETS THIS AS "MILD" POSITIVE ON THE SEVERITY INDICATOR BAR FOR AIRWAY HYPERRESPONSIVENESS. DISPLAYED MEASUREMENT RESULTS ON THE REPORT ARE CORRECT. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469675 VYNTUS CALCULATOR, PULMONARY FUNCTION DATA BZC VYAIRE MEDICAL GMBH V-378510 04250892904863

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other